Journal of pharmaceutical sciences最新文献_第7页

The Vital Role of Biological Standardization in Ensuring Efficacy and Safety of Biological Products - Historical Perspectives.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-20 DOI: 10.1016/j.xphs.2024.12.011

Rajesh K Gupta

{"title":"The Vital Role of Biological Standardization in Ensuring Efficacy and Safety of Biological Products - Historical Perspectives.","authors":"Rajesh K Gupta","doi":"10.1016/j.xphs.2024.12.011","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.12.011","url":null,"abstract":"Biological Standardization has been pivotal to the success of traditional biological products, such as vaccines, antitoxins, and immune globulins, by ensuring their quality and consistency across manufacturers worldwide. The principles of biological standardization have similarly supported the development and manufacture of safe and effective modern biological products, including hormone, therapeutic protein, and monoclonal antibody products, and continue to play a vital role in advancing new cutting-edge biological products, such as tissue, cellular, and gene-therapy products. Biological standardization started with the physical standards ensuring the reliability and suitability of methods used to test biological products and science of bioassays or biological methods and related biostatistics providing a framework for evaluating biological, functional activity or potency of these products. It expanded to include written standards defining the quality requirements for manufacturing and regulation of biological standards. Due to the shift in biologics industry from public health to commercial driven enterprises during the past 50 years, the biological standardization program has evolved to include the product-specific reference standards and harmonization of physical standards. The global success of conventional vaccines in controlling numerous deadly infectious diseases can largely be attributed to the availability of physical and written international standards developed through a strong biological standardization program. This article explores the evolution of biological standardization for more than a century, its scientific and regulatory principles, challenges from disruption in international standardization efforts, and future perspectives for the field.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comparative Analysis of Polystyrene versus Zirconia Beads on Breakage Kinetics, Heat Generation, and Amorphous Formation during Wet Bead Milling.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-20 DOI: 10.1016/j.xphs.2024.11.029

Gulenay Guner, Hamidreza Heidari, Kaitlyn Lehman, Parind M Desai, Don Clancy, Ecevit Bilgili, Sayantan Chattoraj

{"title":"Comparative Analysis of Polystyrene versus Zirconia Beads on Breakage Kinetics, Heat Generation, and Amorphous Formation during Wet Bead Milling.","authors":"Gulenay Guner, Hamidreza Heidari, Kaitlyn Lehman, Parind M Desai, Don Clancy, Ecevit Bilgili, Sayantan Chattoraj","doi":"10.1016/j.xphs.2024.11.029","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.11.029","url":null,"abstract":"This study determined process conditions under which polystyrene (CPS) and zirconia (YSZ) beads cause similar breakage kinetics and temperature rise during manufacturing of drug nanosuspensions via wet bead milling and explored relative advantages of CPS beads, particularly for stress-sensitive compounds. Besides temperature and particle size measurements, a microhydrodynamic-based kinetic model simulated the conditions for CPS to achieve breakage rates equivalent to those of YSZ. A power law correlation was applied to find conditions conducive to temperature equivalency. The maximum contact pressure and pseudo energy dissipation rate were calculated under these equivalency conditions. When bead loading for CPS was increased to match with YSZ, lower temperature at similar breakage conditions or faster breakage at the same temperature was achieved. Increasing the tip speed did not provide any notable advantages for CPS over YSZ in terms of breakage kinetics or temperature. However, under all conditions investigated, CPS beads exhibited markedly lower maximum contact pressure and pseudo energy dissipation rate, which may correlate with reduced mechanically induced amorphization during milling. A proof-of-concept study demonstrated that a mechanical stress-sensitive drug had lower amorphous generation with CPS compared to YSZ. Therefore, CPS beads are a promising alternative to YSZ beads, especially when used at the highest feasible loading.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142877491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Development of Lacosamide-loaded In-Situ Gels through Experimental Design for Evaluation of Ocular Irritation In Vitro and In Vivo.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-18 DOI: 10.1016/j.xphs.2024.11.027

Özlem Çoban, Sıla Gülbağ Pınar, Heybet Kerem Polat, Gülşah Gedik, Nasıf Fatih Karakuyu, Esra Pezik, Sedat Ünal, Behzad Mokhtare, Aleyna Akşit

{"title":"Development of Lacosamide-loaded In-Situ Gels through Experimental Design for Evaluation of Ocular Irritation In Vitro and In Vivo.","authors":"Özlem Çoban, Sıla Gülbağ Pınar, Heybet Kerem Polat, Gülşah Gedik, Nasıf Fatih Karakuyu, Esra Pezik, Sedat Ünal, Behzad Mokhtare, Aleyna Akşit","doi":"10.1016/j.xphs.2024.11.027","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.11.027","url":null,"abstract":"Lacosamide (LCM) selectively increases the slow inactivation of voltage-gated sodium channels (VGSCs) and is a N-methyl D-aspartate acid (NMDA) receptor glycine site antagonist. Therefore, it can be used in dryness-related hyperexcitability of corneal cold receptor nerve terminals. Ocular in-situ gels remain in liquid form until they reach the target site, where they undergo a sol-gel transformation in response to specific stimuli. They can show mucoadhesive properties related to the polymer used and increase the residence time of the drug in the mucosa. In the presented study, ocular in-situ gel formulation of LCM, which has potential for use in ocular diseases and consists of hyaluronic acid and poloxamer 407 as polymers, was developed using cold method. The effect of formulation components on target product properties (pH, gelation temperature and viscosity) was evaluated by design of experiments (DoE) design. The optimized LCM-loaded in-situ gel had a pH value of 6.90 ± 0.01, showed pseudo-plastic flow with a viscosity of 562 ± 58 cP at 25°C, gelled at 33 ± 0.47°C, and released drugs via the Peppas-Sahlin mechanism. Ocular safety was confirmed via in vitro tests using two different cell lines (L929 and Arpe-19), along with in vivo Draize tests, histological examinations, and Hen's Egg Chario-Allontioc-Membrane (HET-CAM) analysis. In vitro studies confirmed the optimized LCM-loaded in-situ gel's suitability for ocular use, demonstrating long-acting effects through controlled release. In addition, ocular irritation and histological studies have supported that it will not show any toxic effect on the eye tissue.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142870845","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Targeted thermosensitive liposomes loaded with gold nanoparticles and temozolomide hexadecanoate for the synergistic photothermal-chemotherapy treatment of glioblastoma.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-18 DOI: 10.1016/j.xphs.2024.11.030

Xinliu Duan, Aiping Wang, Li Jiang, Xuan Zhou, Jiewen Zhao, Xu Deng, Liuxiang Chu, Yueli Liu, Yanyan Jiang, Wenjing Song, Kaoxiang Sun

{"title":"Targeted thermosensitive liposomes loaded with gold nanoparticles and temozolomide hexadecanoate for the synergistic photothermal-chemotherapy treatment of glioblastoma.","authors":"Xinliu Duan, Aiping Wang, Li Jiang, Xuan Zhou, Jiewen Zhao, Xu Deng, Liuxiang Chu, Yueli Liu, Yanyan Jiang, Wenjing Song, Kaoxiang Sun","doi":"10.1016/j.xphs.2024.11.030","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.11.030","url":null,"abstract":"Glioblastoma (GBM) is a highly aggressive malignant brain tumour which presents a significant challenge due to the limited effectiveness of current surgical and chemotherapeutic approaches. In this study, we have developed TMZ16e and gold nanoparticles coencapsulated thermosensitive liposomes modified with anti-EphA3 (anti-EphA3-TMZ16e-GNPs-TSL) delivered via the intranasal route to achieve photothermal chemotherapy (PCT) for improving the therapeutic effects of GBM. The prepared anti-EphA3-TMZ16e-GNPs-TSL were spherical with a particle size of 173.7±1.2 nm with toxicity tests confirming their excellent safety for the nasal mucosa. Furthermore, an elevated temperature (42.2°C) was observed under 780 nm infrared irradiation, which resulted in the targeted release of TMZ16e. In vitro, cellular assays demonstrated that the cytotoxicity in the anti-EphA3-TMZ16e-GNPs-TSL group were significantly higher (55%) than other groups upon laser irradiation (p < 0.01). In vivo, thermographic analysis revealed a significant increase in brain temperature (42.4°C) in the anti-EphA3-TMZ16e-GNPs-TSL group. The combination therapy resulted in a significant increase in tumor cell apoptosis and a median survival time of 47 days, which was 1.38 and 1.68 times longer than that observed in rats treated with chemotherapy or photothermal therapy, respectively. H&E and TUNEL staining results that PCT induce apoptosis in GBM cells. This targeted PCT system represents a promising treatment strategy for GBM, offering a more precise and potent therapeutic intervention that could potentially improve patient prognosis and quality of life.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

AURA: Accelerating Drug Discovery with Accuracy, Utility, and Rank-Order Assessment for Data-Driven Decision Making.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-18 DOI: 10.1016/j.xphs.2024.12.006

Edward Price, Virginia Saulnier, Cory Kalvass, Stella Doktor, Manuel Weinheimer, Majdi Hassan, Spencer Scholz, Marjoleen Nijsen, Gary Jenkins

{"title":"AURA: Accelerating Drug Discovery with Accuracy, Utility, and Rank-Order Assessment for Data-Driven Decision Making.","authors":"Edward Price, Virginia Saulnier, Cory Kalvass, Stella Doktor, Manuel Weinheimer, Majdi Hassan, Spencer Scholz, Marjoleen Nijsen, Gary Jenkins","doi":"10.1016/j.xphs.2024.12.006","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.12.006","url":null,"abstract":"Biopharmaceutical companies generate a wealth of data, ranging from in silico physicochemical properties and machine learning models to both low and high-throughput in vitro assays and in vivo studies. To effectively harnesses this extensive data, we introduce a statistical methodology facilitated by Accuracy, Utility, and Rank Order Assessment (AURA), which combines basic statistical analyses with dynamic data visualizations to evaluate endpoint effectiveness in predicting intestinal absorption. We demonstrated that various physicochemical properties uniquely influence intestinal absorption on a project-specific basis, considering factors like intestinal efflux, passive permeability, and clearance. Projects within both the \"Rule of 5\" (Ro5) and beyond \"Rule of 5\" (bRo5) space present unique absorption challenges, emphasizing the need for tailored optimization strategies over one-size-fits-all approaches. This is corroborated by the improved accuracy of project-specific correlations over global models. The differences in correlations between and within project teams-due to their unique chemical spaces-highlight how complex and nuanced the prediction of intestinal absorption can be. Here, we implement a standardized methodology, AURA, that any organization can incorporate into their workflow to enhance early-stage drug optimization. By automating analytics, integrating diverse data types, and offering flexible visualizations, AURA enables cross-functional teams to make data-driven decisions, optimize workflows, and enhance research efficiency.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142872393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

How the Magenstrasse Is Formed After Meals: Protein Aggregation Hypothesis.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-17 DOI: 10.1016/j.xphs.2024.12.008

Ryosuke Sakai, Yoshiyuki Shirasaka, Taiyo Takagi, Takato Masada, Keiko Minami, Makoto Kataoka, Ikumi Tamai, Toshihide Takagi, Shinji Yamashita

{"title":"How the Magenstrasse Is Formed After Meals: Protein Aggregation Hypothesis.","authors":"Ryosuke Sakai, Yoshiyuki Shirasaka, Taiyo Takagi, Takato Masada, Keiko Minami, Makoto Kataoka, Ikumi Tamai, Toshihide Takagi, Shinji Yamashita","doi":"10.1016/j.xphs.2024.12.008","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.12.008","url":null,"abstract":"Magenstrasse (stomach road) is reported to potentially influence the absorption of orally administered drugs by facilitating a gastric emptying of ingested water under postprandial condition. We hypothesized the Magenstrasse is a consequence of the formation of protein aggregates due to the decrease in gastric pH associated with stimulated gastric acid secretion. The formation mechanism of the Magenstrasse was examined in vitro using a gastric chamber system which reproduces postprandial conditions in the stomach. Oral liquid meals containing different amounts of proteins were mixed with simulated gastric fluid containing pepsin in the gastric chamber. When a high-protein liquid meal was used, infusion of gastric acid caused protein denaturation, generating semisolid aggregates. Then, to evaluate the impact of the aggregates, fluorescein isothiocyanate-dextran 4000 (FD-4) solution was added. The presence of protein aggregates facilitated the elution of FD-4 from the gastric chamber, indicating that the semisolid aggregates suppressed mixing of FD-4 solution with meals. In addition, formation of the same type of protein aggregates was observed in vivo in rat stomach after ingesting a high-protein liquid meal. These in vitro and in vivo results support the idea that protein aggregation of liquid meals in the stomach contributes the formation of the Magenstrasse.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864624","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Why a Complementary Analytical Toolbox is Essential for Correct siRNA Duplex Content Determination.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-16 DOI: 10.1016/j.xphs.2024.12.009

Laure-Elie Carloni, Tiny Deschrijver, Kirsten Ryvers, Bart Noten, Lukas M Stratmann, Thomas De Vijlder

{"title":"Why a Complementary Analytical Toolbox is Essential for Correct siRNA Duplex Content Determination.","authors":"Laure-Elie Carloni, Tiny Deschrijver, Kirsten Ryvers, Bart Noten, Lukas M Stratmann, Thomas De Vijlder","doi":"10.1016/j.xphs.2024.12.009","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.12.009","url":null,"abstract":"Small interfering RNAs (siRNAs) have emerged as a highly promising class of therapeutics, capable of effectively treating a wide range of indications, including previously challenging targets. To correctly characterize the duplex content of siRNA therapeutics, a careful design of the analytical conditions is required. This is due to the weak interactions governing the duplex formation and thermal stability of these double-stranded oligonucleotides. In this study, we demonstrate that the reliability of duplex content analyses can be compromised by denaturation or hybridization artifacts caused by environmental factors related with sample preparation or with the 'non-denaturing' chromatographic analysis method. To address this issue, we propose to characterize the siRNA duplex in various analytical media with unbiased techniques such as circular dichroism spectrophotometry and use the results to evaluate potential artifacts in the 'non-denaturing' method, developed to determine the duplex content. Through this approach, one can optimize the sample preparation and develop 'non-denaturing' method conditions to minimize the influence of environmental factors on the duplex content, and thereby determine the assay of siRNA duplex with no bias.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Pharmacokinetics and safety of pirfenidone in individuals with chronic kidney disease (CKD) stage G2 and G3a: a single-dose, Phase I, Bridging study.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-16 DOI: 10.1016/j.xphs.2024.11.020

Dianwen Yu, Rui Zhang, Jinping Zhou, Pengpeng Guo, Peixia Li, Menghan Ye, Yani Liu, Shaojun Shi

{"title":"Pharmacokinetics and safety of pirfenidone in individuals with chronic kidney disease (CKD) stage G2 and G3a: a single-dose, Phase I, Bridging study.","authors":"Dianwen Yu, Rui Zhang, Jinping Zhou, Pengpeng Guo, Peixia Li, Menghan Ye, Yani Liu, Shaojun Shi","doi":"10.1016/j.xphs.2024.11.020","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.11.020","url":null,"abstract":"Background and objective: Pirfenidone is an inhibitor of transforming growth factor-beta 1 (TGF-β1) and is being developed for the treatment of diabetic kidney disease (DKD). We assessed the pharmacokinetics (PK) and safety of a single dose of pirfenidone in individuals with CKD stages G2/G3a.Methods: In this phase I bridging study, patients with CKD stages G2 or G3a, aged 18-70 years, with a body mass index of 18-26 kg/m2, and glomerular filtration rate (eGFR) ranging from 45 to 89 ml/min/1.73m2, received a single oral dose of 400 mg pirfenidone capsules 30 minutes after a standard breakfast. The pharmacokinetic parameters of the two groups were measured and compared after blood and urine collection. The co-primary endpoints were the area under the plasma concentration-time curve from time zero to 36 hours (AUC0-36) and the maximum observed plasma concentration (Cmax) of pirfenidone. Safety was a secondary endpoint. The trial has been registered on ClinicalTrials.gov (ChiCTR2300077297).Results: A total of 20 subjects participated in this study. There were no significant differences between the control group and the patient group (CKD stages G2/G3a) in terms of plasma Cmax, the time to reach the maximum observed concentration (Tmax), and elimination half-life(t1/2). However, the Vz/F of the patient group (CKD G2 stage) was significantly higher than that of the control group. Renal accumulation rate, renal clearance rate (CLr), and urine drug concentration also showed no significant differences. No severe adverse events occurred during the trial.Conclusions: These results indicate that the PK and safety of pirfenidone are not influenced by renal function. Individuals with renal impairment may not require dose adjustments.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Recent Advances in Drying and Development of Solid Formulations for Stable mRNA and siRNA Lipid Nanoparticles.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-16 DOI: 10.1016/j.xphs.2024.12.013

Kinnari Santosh Arte, Manlin Chen, Chanakya D Patil, Yijing Huang, Li Qu, Qi Zhou

{"title":"Recent Advances in Drying and Development of Solid Formulations for Stable mRNA and siRNA Lipid Nanoparticles.","authors":"Kinnari Santosh Arte, Manlin Chen, Chanakya D Patil, Yijing Huang, Li Qu, Qi Zhou","doi":"10.1016/j.xphs.2024.12.013","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.12.013","url":null,"abstract":"Current RNA lipid nanoparticle (LNP) based products are typically liquid formulations that require ultra-cold storage temperatures for stability. To address this limitation, recent efforts have focused on enhancing stability and enabling room temperature storage by converting these formulations into solid forms through drying processes such as lyophilization, spray drying, and spray-freeze drying. Nevertheless, the drying process itself can influence the stability of RNA/LNP formulations. Therefore, understanding the factors that contribute to instability during drying is essential. The choice of drying technique for LNPs depends on factors such as the mode of delivery, lipid components, and desired final product characteristics. Additionally, the drying mechanism and associated stresses must also be carefully considered. Drying methods involve a range of process parameters related to formulation, process settings, and the manufacturing environment. It is essential to understand how these parameters influence the final solid-state products' attributes, including appearance, moisture content, flow properties, and reconstitution time, as these can significantly affect the physical and chemical stability of the formulation. This review focuses on various drying techniques and their impact on the stability of RNA/LNP-based systems.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Spray Drying Process Challenges and Considerations for Inhaled Biologics- A Review.

IF 3.7 3区医学

Journal of pharmaceutical sciences Pub Date : 2024-12-16 DOI: 10.1016/j.xphs.2024.11.028

Sadegh Poozesh, Patrick Connaughton, Scott Sides, David Lechuga-Ballesteros, Sajal M Patel, Prakash Manikwar

{"title":"Spray Drying Process Challenges and Considerations for Inhaled Biologics- A Review.","authors":"Sadegh Poozesh, Patrick Connaughton, Scott Sides, David Lechuga-Ballesteros, Sajal M Patel, Prakash Manikwar","doi":"10.1016/j.xphs.2024.11.028","DOIUrl":"https://doi.org/10.1016/j.xphs.2024.11.028","url":null,"abstract":"Spray drying presents numerous advantages over other drying technologies, particularly for inhaled biologics because of the fine-tuned particle attributes requirements. To fully leverage these benefits, it is crucial to address several process challenges and considerations throughout the end-to-end spray-drying process, including stages prior to, during, and post- drying. This review provides a detailed overview of the challenges associated with spray-drying of biologics along with the aspects of protein degradation. Furthermore, it delineates the entire spray-drying process, comprising feed solution preparation, spray drying, and bulk powder handling, along with protein degradation mechanisms and analytical tools for protein and aerosol performance assessment. Pertaining to inhaled biologic products, this review also sheds light on major bottlenecks and potential challenges, particularly during scale-up. While some challenges are yet to be conclusively addressed, potential control and mitigation strategies from industry perspective are presented and examined. Lastly, the review briefly explores trending topics in this field that could add value to the standard spray-drying process and may be incorporated in future drying technologies.","PeriodicalId":16741,"journal":{"name":"Journal of pharmaceutical sciences","volume":" ","pages":""},"PeriodicalIF":3.7,"publicationDate":"2024-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142854442","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0